Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children

Xiamen University

Status: Enrolling

Conditions: Efficacy; Children; Rituximab; Nephrotic Syndrome

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Other

Identifiers

NCT06530004

XDFY-EK-BHT

Details and patient eligibility

About

This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children clinically diagnosed with FRNS/SDNS/SRNS with complete clinical data;
• age < 18 years old;
• For the first time using RTX treatment, and used in nephrotic syndrome ease;
• The follow-up for 1 year or more.

Exclusion criteria

• Congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, IgA nephropathy, purpura nephritis, hepatitis B nephritis, etc.);
• Active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases;
• Estimated glomerular filtration rate (GFR) <60mL/min/1.73m2.

Trial design

50 participants in 2 patient groups

Sequential prevention group

Description:

According to the situation of B cells to rebuild the preventive use of rituxan, each 375 mg/m2.

Treatment:

Drug: Rituximab

Recurrent sequential group

Description:

In patients with recurrence after the use of rituxan, each 375 mg/m2.

Treatment:

Drug: Rituximab